Status:
RECRUITING
Prebiotic Galacto-oligosaccharide and Acute GVHD
Lead Sponsor:
Duke University
Conditions:
Acute GVHD
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether the carbohydrate prebiotic (dietary supplement) known as galacto-oligosaccharide (GOS) can modulate the microbiome (the bacteria in the gut) and help ...
Detailed Description
Humans carry on the order of 100 trillion microbial cells (the microbiota),which play a major role in normal health as well as disease pathogenesis. In the gut, the microbiota interact with the intest...
Eligibility Criteria
Inclusion
- Plan to undergo allogeneic HCT for any cancer or non-cancer illness
- Age 18-80 years
- Karnofsky Performance Status \>70
Exclusion
- Pregnant/lactating
- Malabsorption syndrome, short bowel or chologenic diarrhea
- At time of enrollment, Grade 2 or higher GI symptoms per NCI-CTCAE
- Active treatment with other prebiotics, probiotics, or herbal supplementation (ok if stops before enrollment)
- Active treatment with antibiotics (with the exception of prophylactic antibiotics)
- Concurrent enrollment on the Duke HCT Home Transplant study or another clinical trial targeting GVHD; patients who are enrolled in observational or non-pharmacologic intervention trials (for example, the Duke HCT Research-POP Pre and Peri-HCT Optimization Program aka "R-POP") or pharmacologic or cellular therapy trials with other targets (for example, NK DLI) are NOT excluded
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04373057
Start Date
January 22 2021
End Date
February 1 2028
Last Update
July 1 2025
Active Locations (2)
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1
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
2
Duke
Durham, North Carolina, United States, 27710